The present invention is directed to a coiling clip that grips a plastic tube and use of that clip in a catheter dispenser.
There are many medical procedures where catheters are used. Frequently, other apparatus is used with the catheter. For example, when a catheter is introduced into a patient""s blood vessel such as an artery or vein, guidewires are routinely used.
In a typical procedure, one uses the guidewires for the positioning of a catheter. For instance in the Seldinger technique a catheter introducer is used that has a relatively short flexible cannula that is placed within the patient""s blood vessel. Actual insertion of the cannula is assisted by the use of a needle that is positioned within the cannula and is thus inserted in the blood vessel. Upon insertion, the needle is withdrawn, leaving the cannula tip within the blood vessel while the body of the catheter introducer remains external of the patient.
A guidewire is then inserted through the catheter introducer and is extended through the tip of the cannula within the patient""s blood vessel until it is positioned with its tip at the desired location within the patient. Upon removal of the catheter introducer, the guidewire remains in the patient and a long catheter is easily slid over the guidewire to the desired position and the guidewire withdrawn. Thus, the catheter remains within the patient having its distal end located at the proper position within the patient""s blood vessel.
These catheters can be used for a variety of medical techniques including angioplasty, gene delivery, etc. Thus, the guidewires once introduced into the body can extend to distant sites.
Anytime any object is introduced into the blood stream care must be taken to insure that sterility is maintained and that the object used does not cause infection. One method by which this goal has been met is the trend to single use devices, which are sterilized when made, then shipped and ready to use.
Such guidewires are delivered through normal shipping channels and are subject to considerable handling prior to and during shipment. The guidewire itself is packaged within a protective tube in a coiled form referred to as a xe2x80x9cspiral woundxe2x80x9d dispenser. A typical guidewire introducer is disclosed in U.S. Pat. No. 5,282,479.
Presently, several clips or retainers referred to as xe2x80x9ccoiling clipsxe2x80x9d are used to anchor the coiled tube. These are devices having a smooth inner surface that holds the tube by exerting pressure against the tube wall. FIG. 1 illustrates a prior art clip. However, during transport it is common for a segment of the tube to xe2x80x9cpop outxe2x80x9d of the clip. Thus, before using the device, the physician must waste valuable time inserting the tube back into the clip. Such additional handling can not only waste time, but may compromise the sterility. This can also cause a serious problem for the physician if when using the dispenser a portion of the tube pops out of the clip. Accordingly, there is a need in the art for a coiling clip that more securely anchors the spiral wound dispenser.
The present invention provides an improved coiling clip that overcomes the aforesaid difficulties by providing an increased grip on the protective tube. The improved clip comprises a one-piece plastic clip for coiling a continuous linear flexible material, e.g., a protecting tube, comprising:
(a) two substantially xe2x80x9cCxe2x80x9d-shaped socket members, said socket members having a radius portion that is effective for snugly receiving and releasably holding an elongated piece of linear flexible material which has a circular cross section, said radius portion not being smooth, more preferably being textured, most preferably having extending therefrom a plurality of spaced projections; and
(b) said socket members being connected in side-by-side relationship to hold a pair of linear flexible material portions in the same plane extending through the center of the socket members and in an adjacent relationship with respect to each other. The projections engage the tubing as the tubing is pushed into the clip in order to provide an increased grip by being impressed into the material of the tubing.
In a preferred embodiment, the projections are spaced parallel ribs extending from the surface of the radius.
In one preferred embodiment the two substantially xe2x80x9cCxe2x80x9d-shaped members are disposed with both open ends facing in the same direction. In another embodiment the two substantially xe2x80x9cCxe2x80x9d-shaped members are disposed with the open end of one member facing in one direction and the open end of the other member facing in the opposite direction.
The present invention further includes a method for producing a spiral wound dispenser. The method comprises inserting a portion of a protective tube into a socket of a clip of the present invention; coiling the tube; and inserting a second portion of the tube into an adjacent socket of the clip.